Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo
In the EU, there are approximately 270,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite standard-of-care antihistamine treatment
Dupixent, which inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation, is now approved for patients across seven chronic, inflammatory diseases in the EU
TARRYTOWN, N.Y. and PARIS, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. Eligible patients can use Dupixent as a first-line targeted treatment option.
“The unpredictable nature of chronic spontaneous urticaria leaves patients guessing when they’ll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging,” said Tonya Winders, President & CEO, Global Allergy & Airways Patient Platform. “Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.”
“The approval of Dupixent for certain adults and adolescents with chronic spontaneous urticaria in the European Union represents the first innovation for patients with this disease in over a decade,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL-4 and IL-13, two key drivers of type 2 inflammation, and can offer patients significant improvement in debilitating itch and hives. This approval further demonstrates the ability of Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.”
The approval is based on data from two Phase 3 clinical trials in the LIBERTY-CUPID program. Study A and Study C included 284 patients aged 12 years and older who were symptomatic despite the use of antihistamines and who were naïve to anti-IgE therapy. Both trials assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone and demonstrated Dupixent significantly reduced urticaria activity (a composite of itch and hives), and individual measures of itch and hive severity compared to placebo at 24 weeks. Dupixent also increased the percentage of patients with well-controlled disease and complete response at 24 weeks compared to placebo. Study B included 108 patients and provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.
Safety results from Study A, Study B and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis and injection site hematoma were reported in the CSU adult and adolescent trials. Adverse events more commonly observed with Dupixent (≥5%) than placebo in patients with CSU were injection site reaction, COVID-19, hypertension, CSU and accidental overdose.
“Standard-of-care, first-line treatment options like antihistamines offer limited relief for many people living with uncontrolled chronic spontaneous urticaria, leaving them to face unrelenting cycles of itch and hives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi. “Dupixent significantly reduced these symptoms of CSU and led to more patients experiencing well-controlled disease or a complete response compared to placebo in two Phase 3 studies. Now, eligible patients with CSU in the EU have a new option that is proven to reduce itch and hives.”
Beyond the European Union (EU), Dupixent is also approved for CSU in certain adults and adolescents in several countries including the United States and Japan.
About CSUCSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. More than 270,000 people in the EU aged 12 years and older suffer from CSU that is inadequately controlled by antihistamines.
About the Dupixent CSU Phase 3 Trial ProgramThe LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU consists of Study A, Study B and Study C. These trials were randomized, double-blind, placebo-controlled clinical trials that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone. Studies A and C were replicate trials that assessed patients aged 6 years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three trials, all patients received an initial loading dose followed by either 300 mg Dupixent every two weeks or 200 mg every two weeks for adolescents weighing